FDA 510(k) Applications Submitted by Terang Nusa Sdn Bhd

FDA 510(k) Number Submission Date Device Name Applicant
K990488 02/16/1999 SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE TERANG NUSA SDN BHD
K982957 08/24/1998 SENSIFLEX POWDERFREE SURGEON'S GLOVE TERANG NUSA SDN BHD
K052837 10/06/2005 SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA TERANG NUSA SDN BHD
K000178 01/20/2000 NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN TERANG NUSA SDN BHD
K000179 01/20/2000 NUZONE NITRILE SURGICAL GLOVES POWDER FREE TERANG NUSA SDN BHD
K010439 02/12/2001 MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) TERANG NUSA SDN BHD
K010438 02/13/2001 MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS) TERANG NUSA SDN BHD
K990840 03/15/1999 NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE TERANG NUSA SDN BHD
K990841 03/15/1999 NUGARD NITRIL NITRILE EXAMINATION GLOVE TERANG NUSA SDN BHD
K041436 05/28/2004 SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2 TERANG NUSA SDN BHD
K041437 05/28/2004 MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE TERANG NUSA SDN BHD
K051562 06/13/2005 NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR TERANG NUSA SDN BHD
K051563 06/13/2005 NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED TERANG NUSA SDN BHD
K003545 11/17/2000 NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE TERANG NUSA SDN BHD
K003547 11/17/2000 NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) TERANG NUSA SDN BHD
K051094 04/28/2005 NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE TERANG NUSA SDN BHD
K140355 02/12/2014 SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM TERANG NUSA SDN BHD
K110698 02/17/2011 NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE TERANG NUSA SDN BHD
K170779 03/15/2017 Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein Terang Nusa Sdn Bhd
K151392 05/26/2015 Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less TERANG NUSA SDN BHD
K161932 07/14/2016 Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink Terang Nusa Sdn Bhd
K102119 07/28/2010 SUR-G GLOV AND MAXITEX TERANG NUSA SDN BHD
K102230 08/09/2010 NUGARD NITILE GREY COLOR TERANG NUSA SDN BHD
K083337 11/12/2008 NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES TERANG NUSA SDN BHD
K153510 12/07/2015 Powder Free Polychloroprene Examination Glove Green TERANG NUSA SDN BHD


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